Prescription drug · ANDA
ondansetron hydrochloride NDC 83980-018
Ondansetron hydrochloride 8 mg/1 · Tablet, Film coated · Oral · Ipca Laboratories Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83980-018-10 | 83980001810 | 1000 TABLET, FILM COATED in 1 BOTTLE (83980-018-10)Marketed from Aug 14, 2026 | |
| 83980-018-13 | 83980001813 | 30 TABLET, FILM COATED in 1 BOTTLE (83980-018-13)Marketed from Aug 14, 2026 | |
| 83980-018-97 | 83980001897 | 10 TABLET, FILM COATED in 1 BOTTLE (83980-018-97)Marketed from Aug 14, 2026 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- ondansetron hydrochloride
- Generic name (nonproprietary)
- ondansetron hydrochloride
- Active ingredients
- Ondansetron hydrochloride — 8 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Ipca Laboratories Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203761
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 3 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 83980-018_57713a3e-638c-494d-965e-2399c69dd00fSPL ID 57713a3e-638c-494d-965e-2399c69dd00fSPL set ID 7ab3210e-eed1-479a-afc0-f72b5b776883RxCUI 198052, 312086UNII NMH84OZK2BUPC 0383980018136, 0383980017139
- Pharmacologic class
- Serotonin-3 Receptor Antagonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N483980001810followed by a unit qualifier and the quantityPackage 83980-0018-10. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Ondansetron is a 5-HT 3 receptor antagonist indicated for the prevention of: nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m 2 . ( 1 ) nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. ( 1 ) nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. ( 1 ) postoperative nausea and/or vomiting. ( 1 ) Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: highly emetogenic cancer chemotherapy, including…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203761
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| ondansetron hydrochloride | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | Ipca Laboratories Limited | 83980-017 |